Thick-walled flexible probe for insertion in the trachea or respectively in the bronchial system

ABSTRACT

Tubular flexible probe for insertion in the wind-pipe or in the bronchial system, in particular for use as a suction catheter with a tube (10) having an outside diameter of roughly 5-8 mm and a length of roughly 30-50 cm. Its end, which can be inserted in the wind-pipe or in the bronchial system can be designed as an annular collar (12) and in the region of the annular collar may have holes (21) with at least one channel (2) having a diameter of about 1 to a maximum of 2 mm for the conveyance of medicaments. Its inlet (23) is provided with a connection piece (3) for attachment of a syringe.

The invention relates to a tubular flexible probe for insertion in thetrachea or, respectively, in the bronchial system, especially for use asa suction catheter, with a duct formed by a tube having a length ofabout 30 to 50 cm and an outer diameter of about 5 to 8 mm, the end ofthis duct, which can be introduced into the bronchial system, beingfashioned optionally as an annular collar and, if desired, exhibitingvent holes in the zone in front of the annular collar.

Probes of the type described above, as known, for example, from DAS No.2,364,119, are utilized for removing, by suction, mucus and water fromthe lungs and the trachea. The tubular flexible catheter has an outerdiameter of about 5-8 mm with an internal diameter for the suction ductof about 3.5-6 mm. The annular collar formed at the end introduced intothe bronchial system facilitates introduction and prevents adherence bysuction and injuries to the mucous membrane and the bronchi. Suchcatheters are intended for one-time, short-term usage.

Efforts have been made in recent times to introduce medicaments directlyinto the lung of the affected person in the treatment of emergencies.When using the conventional suction catheters for this purpose, there isthe grave disadvantage that the medicaments must be introduced, afteraspiration, through the suction duct and pass down into the lungs onlyin minor proportions on account of the size of the duct, while theyotherwise remain in the catheter tube. The objective of introducing themedicaments completely and deeply into the lung and to distribute themtherein is not achieved. Also, the known catheters are not equipped withattachments for fitting a syringe.

For respiration and oxygenation, so-called respirator tubes or ballooncatheters are known for long-term usage; these are introduced only intothe trachea and are unsuited for use as suction catheters since theiropen, beveled end would lead to considerable injuries to the bronchialtissue. In the respirator tube according to DOS No. 2,308,400, suctionremoval is to be made possible besides providing respiration, and forthis purpose a catheter is guided coaxially through the tube, reducingand impeding the tube cross section. This is of no consequence inrespiration, but presents a drawback in aspiration of the bronchi andlungs through this tube inasmuch as clogging of the cross section canoccur. Furthermore, in case of the respirator tube according to DOS No.2,308,400, aspiration can be performed only intermittently duringexhaling. Irrigation and simultaneous suctioning off of secretions isimpossible with the respirator tube according to DOS No. 2,308,400since, with the irrigation fluid being supplied via the catheter,suction will have to be effected via the tube. As a consequence, therespirator tube would adhere by suction to the bifurcation, resulting indiffuse, gravest hemorrhaging with highest danger to life. The necessaryrespiration and, respectively, oxygen exchange cannot be performedsimultaneously during irrigation and suctioning.

The invention is based on the object of providing a probe or a catheterwith which medicaments can be introduced through the trachea and,respectively, bronchi to deeply into the bronchial system and,respectively, the lungs, optionally in conjunction with aspiration.

The invention attains the thus-posed object by means of a tubularflexible probe suitable for introduction into the trachea or,respectively, the bronchial system, by providing that the tube exhibitsat least one duct having a diameter of about 1 mm up to maximally about2 mm for passing medicaments and/or irrigation solution therethrough,the inlet of which tube can be equipped with an attachment forconnecting a syringe, and the outlet of which terminates within the tubeor at the tube end.

The invention is based on the realization that a maximally high pressuredifference is required between the ends of the probe in order to obtainthereby a high flow rate for the deep introduction and distribution ofmedicaments into the lung. For this purpose, very small duct crosssections are necessary along the lines of the invention. A hose havingsuch a small duct diameter exhibits, in case the wall thickness is ofnormal design, an outer diameter which is not much larger and thereforeis so flexible that it can no longer be perfectly introduced into thebronchial system.

The invention is based on a probe suitable for introduction into thebronchial system with external dimensions of a size and configuration asknown for the suction removal of mucus and water from the lungs, andsuch a probe is fashioned, in accordance this invention, with a ducthaving such a small cross section that a high pressure difference ismade possible for the deep introduction of medicaments into the lung ata high flow rate. At the same time, the inlet of this medicament duct isequipped with a connecting piece for the attachment of a syringe; theconnecting piece can be designed as a separate component or can befashioned integrally with the tube or, respectively, the duct.

The probe can be fashioned in accordance with the invention so that itpermits either solely the introduction of medicaments by means of asingle, small duct present--medicine duct or administering duct--or thealternative introduction of medicaments through the administering ductand aspiration through the second duct, i.e. the aspiration duct. Incase the probe is to serve exclusively for the administration ofmedicines, then the probe can be fashioned, according to a suggestion ofthis invention, so that the administering duct extends within the largeduct of the tube and is constituted, for example, by a hose arranged inthe large duct. The outer diameter of the hose must in any event besmaller than the inner diameter of the large duct. Preferably, the hoseinserted in the tube should have an outer diameter of about 2 mm. Thehose is likewise manufactured from a flexible, supple, sterilizablematerial, e.g. a synthetic resin. The hose must be equipped in its inletzone with an attachment for a syringe connected to the inlet zone of thelarge duct of the tube. For example, the attachment or connecting piececan be manufactured integrally with the tube or hose, i.e. it can be ofone piece therewith. The attachment herein serves for the placement of asyringe for introducing medicaments; in this connection, the attachmentcan also be additionally provided, for example, with a valve or aclosure means.

It is also possible to fashion the probe according to this inventionwith a tube having an outer diameter of about 5 mm to 8 mm and with onlya single, very small duct having a diameter of about 1-2 mm solely forpassing therethrough medicaments at a high flow rate. The size of thetube takes care of the perfect introduction into the bronchial system.The attachment for the syringe can be molded directly at the tubeend--fashioned integrally with a continuous duct or bore. The tube isdistinguished by a relatively large wall thickness of at least about 1.5mm. Only very supple, soft, flexible plastics can then be utilized forthis purpose. In these probes of a structure in accordance with theinvention, the tube end to be introduced into the trachea can also bedesigned to taper in a rounded fashion, in place of an annular collar.In particular, it is also possible to arrange the outlet of the smalladministering duct on the jacket surface of the tube in the zone of thetube end.

For using the probe in accordance with this invention alternatingly as asuction catheter and for the administration of medicaments and/orirrigation solution, it is proposed that the tube exhibit twoparallel-juxtaposed ducts of differing diameters, wherein the ducthaving a diameter of about 1 to 2 mm in all cases is the duct with thesmaller diameter.

In accordance with this version of the invention, the large duct of theprobe serves for the aspiration of mucus, and the additional duct havingthe very much smaller diameter serves for the introduction ofmedicaments directly down into the lung. The medicaments are injected byway of a syringe into this small duct wherein a high pressure can bebuilt up so that the medicaments are injected deeply into the lung andat the same time are satisfactorily distributed. The second duct canterminate either still within the tube upstream of the tube end oralternatively flush with the end of the tube. The tube, in all probes,has a length of about 30-50 cm; it is made of a supple, flexible andsterilizable material, e.g. a synthetic resin. The tube can have anouter diameter of about 5-8 mm, the duct diameter for suction removal ofmucus being about 3-4 mm. The duct for introducing the medicaments intothe lungs should have an inside diameter of about 1-11/2 mm up tomaximally 2 mm.

Also this probe preferably exhibits an annular collar at the endintroducible into the bronchial system in order to facilitate insertionand can be fashioned with lateral openings at the tube in the proximityof the annular collar, preventing adherence due to suction at the mucousmembranes. An advantageous embodiment of the probe with two ductsextending in side-by-side relationship provides that the wall of thetube defining the duct with the smaller diameter exhibits a recess inthe region of the inlet end of the tube through which a connecting hoseequipped with an attachment for a syringe is extended into the duct oris connected to the latter. A connecting piece for aspiration can beinserted, for example stuck into the inlet end of the tube into thelarge duct. The connecting pieces for suction removal can be fashionedwith a valve or a closure means. A probe equipped according to thisinvention with two ducts running side-by-side for introduction into thebronchial system can be utilized in such a way that either solelymedicaments are introduced or, alternatively, aspiration is performedthrough the large duct and then, alternatingly, irrigation solution ormedicaments are introduced into the lung through the small duct.

The connecting pieces for the syringes are advantageously equipped witha closure means, such as a valve, a plug, a hinged cover. Furthermore,it is possible in accordance with a further proposal of the invention toequip the tube wall in the axial longitudinal extension with an X-raycontrast strip. Accordingly, control by X-rays is possible during thetreatment.

By means of the invention, a considerable advance in the art of thetreatment of patients is attained in the medical field here underconsideration. Heretofore, it has merely been possible duringresuscitation to operate with the appliances present, in the followingsequence:

(1) Introduction of a respirator tube into the trachea.

(2) Introduction of irrigation solution into the respirator tube.

(3) Ventilation with a respirator bag for distribution of the irrigationfluid.

(4) Introduction of a suction catheter with exclusive suctioning.

(5) Removal of suction catheter.

(6) Introduction of a cava catheter, incurring the dangers of injury tothe mucous membrane (stopgap solution).

(7) Introduction of emergency medicaments via the cava catheter.

(8) Removal of cava catheter.

(9) Initiation of volume-controlled respiration.

The time required for this purpose is, in total, about 3 to 31/2minutes.

With this therapy, damage due to lack of oxygen supply to the emergencypatient cannot be excluded. Also, adequate administration of theemergency medicaments through the cava catheter is not always ensured.In addition, there is the large amount of material consumed, requiring alot of labor and being uneconomical.

The invention makes it possible to take care of the emergency patient asfollows:

(1) Introduction of the respirator tube into the trachea.

(2) Introduction of the probe, fashioned as an irrigation and suctioncatheter, by way of the trachea.

(3) Simultaneous irrigation and aspiration of the bronchial tract bymeans of the probe.

(4) Subsequent deep administration of emergency medicaments by means ofthe probe into the lung.

(5) Removal of the probe.

(6) Initiation of volume-controlled respiration by means of therespiration tube.

Duration of the entire treatment is 30 seconds to 1 minute.

By use of this invention, a substantially faster treatment of theemergency patient is made possible, considerably raising chance ofsurvival. Damage to the central nervous system can be reduced to theutmost minimum. Moreover, the labor to be expended in this procedure issubstantially less, and so is the usage of material.

The invention is described in the drawing with the aid of examples butis not limited thereto.

In the drawing, in schematic representation:

FIG. 1 shows a view of a probe with a small duct solely foradministration of medicaments arranged within the large duct.

FIG. 2 is a plan view of the end of the probe according to FIG. 1.

FIG. 3 is a view of a probe with two ducts extending in side-by-siderelationship for administration and aspiration.

FIG. 4 is a plan view of the end of the probe according to FIG. 3.

FIG. 5 shows the inlet end with a probe according to FIG. 3 withconnections.

FIGS. 6-8 are longitudinal sectional views of various probes withrespectively one duct for administration purposes.

FIG. 9 is a fragmentary longitudinal section through a double-lumenprobe.

The probe for introduction into the bronchial system, fashioned solelyfor the direct conveyance of medicaments into the lung, contains inaccordance with FIG. 1 the outer tube 10. The tube 10 is manufactured,for example, from an inert synthetic resin hose and is flexible. Thetube 10 is designed with the annular collar 12 at its end that can beintroduced into the trachea. In the zone upstream of the annular collar12, the tube 10 can exhibit holes 11. The tube 10 contains thecontinuous duct 1 having, for example, a diameter of about 3-4.5 mm. Incase a coupling for an aspiration procedure is attached, for example, tothe inlet end 13 of the tube 10, then such a tube 10 serves for theaspiration of mucus and water from the lung. In order to introducemedicaments into the lung, the tube 10 is then equipped with a further,very much smaller duct 2 located, for example, within the duct 1. Thesecond, smaller duct is constituted, for example, by a hose 20 connectedwith the attachment 3 at the inlet end 23 by insertion in the continuousduct 31 of the attachment 3. It is also possible to fashion theattachment as early as during manufacture as an integral part of thehose end. The attachment 3 is inserted in the open inlet end 13 of thetube 10 in the duct 1, or firmly connected to the latter in some otherway. It is also possible to fashion the attachment during themanufacture of the tube integrated therewith in one piece at the end. Byway of the duct 31, it is possible by means of a syringe to inject amedicament solution into the lung through the small duct 2 extendedwithin the tube 10 in the duct 1, upon introduction into the bronchialsystem. In this procedure, a high pressure difference is built up in thesmall duct 2 having a diameter of 1 up to maximally 2 mm; this pressuredifference imparts to the medicament solution a high flow rate so thatthe solution is introduced deep into the lung and with finedistribution. The size of the outer dimensions of the tube 10 ensuresthat the hose 20 with the duct 2 can be readily introduced into thebronchial system. The hose end 21 can terminate still within the tube 10or alternatively can end flush with the annular collar 12, i.e. with thetube end 15. FIG. 2 shows a perspective view of the end of the probeintroducible into the trachea, according to FIG. 1. The probe of FIGS. 1and 2 is utilized practically only for the introduction of medicamentsdirectly into the lung by insertion of the probe in the bronchial systemand injection of the medicaments by means of a syringe via the duct 2.On account of the firm outer tube 10 surrounding the hose 20 with thesmall duct 2, a perfect introduction of the hose 20 into the bronchialsystem is ensured.

FIGS. 3-5 show another embodiment of a probe for the introduction ofmedicaments into the lung. According to FIG. 3, the outer tube 10,having an outer diameter of about 7 mm, is designed with two ducts 1, 2extending in parallel in side-by-side relationship. At the end 15 of thetube 10 that can be introduced into the trachea, an annular collar 12 ismolded thereto serving for facilitating the introduction of the probeinto the trachea. In this arrangement, holes 11 should be provided inthe wall of the tube in the region of the tube end upstream of theannular collar 12, which are to prevent adherence of the tube 10 bysuction at the mucous membranes. The perspective view of the insertionend of the tube 10, i.e. the probe according to FIG. 4, likewise depictsthe arrangement and configuration of the two ducts 1, 2 with differingdiameters. The duct 1, having a diameter of about 3-8 mm, depending onthe outer diameter of the tube, serves for the aspiration of secretions,water, and mucus from the lung whereas the very much smaller duct 2,having a diameter of about 1 to maximally 2 mm, serves for theintroduction of medicaments or irrigation solutions into the lung. Theprobe according to FIG. 2 represents a double-lumen catheter for theintrabronchial aspiration of secretion and administration of medicamentsand/or irrigation solutions. A connection for aspiration can beattached, for example, to the inlet end 13 of the large duct 1 of theprobe according to FIG. 3. For connecting the small duct 2 according toFIG. 3, the recess 14 is formed in the wall of the tube in the zone ofthe inlet end 13 of the tube 10, through which recess a connection, e.g.in the shape of a hose piece 4, can be introduced into the inlet 23 ofthe duct, or is fixedly joined to the latter. At the end 41, theattachment for a syringe can be connected to the elastic hose piece 4,or such attachment can be formed directly integrally with the hose end41 so that the medicaments can be introduced via the attachment and thehose 4 into the duct 2 and thus through the trachea into the lung. Theduct 1 and the duct 2 are bulkheaded with respect to each other by thepartition 16.

Thus, by means of the probes of a structure according to this invention,it is possible during emergency treatment of human patients toadminister medicaments deeply and safely into the bronchial system andinto the lung, and in the same operating step, in case of the designwith ducts extending in parallel side-by-side, mucus and secretions canbe suctioned off beforehand.

In the usage of the double-lumen probe according to the invention,irrigation and aspiration can also be performed while respirating iscarried out, i.e. without disconnection of a respirator unit via theaccess of a right-angle, dual rotary connector at the tube.

FIG. 5 shows schematically the connection and structure of connectingpieces 5 for the aspiration procedure and of attachments 3 for thesyringes 6 of a probe according to FIGS. 3 and 4. At the inlet end 13into the duct 1 of the tube 10, the connecting piece 5 is inserted withthe conical end 52. The attachment 5 exhibits the continuous bore 54which can be closed by means of the valve 51. For attaching anaspirator, the connecting piece 5 furthermore exhibits the conical tap53.

For the introduction of medicaments or irrigation solutions by means ofa syringe 6 into the duct 2, the free hose end 4 is equipped with theattachment 3. The attachment 3 has the continuous bore 31 sealable bymeans of a valve 32, designed as a three-way cock, for example. One endof the attachment 3 is connected to the hose end 4 while, at the otherend, the syringe 6 can be inserted in the bore 31. Also otherattachments can be utilized.

FIG. 9 shows, in a fragmentary cross section, the structure of the end15 of a double-lumen probe, this probe exhibiting at the end the annularcollar 12 and holes 11 and wherein the smaller duct 2 terminates withinthe tube 10, preferably still upstream of the holes 11, and at thispoint already passes into the duct 1. The partition 16 between the ducts1, 2 ends upstream of the holes 11 in this embodiment.

In FIGS. 6-8, various embodiments of probes of this invention with alumen are illustrated, utilized as catheters for intrabronchialadministration of medicaments.

In the probe according to FIG. 6, the attachment 3 for the syringe isformed integrally with the thick-walled tube 10, and the annular collar12 is formed at the tube outlet 15. The small medicament duct 2 extendsaxially through the inlet 23 up to the outlet 21 at the tube end.

In the probe of FIG. 7, the tube end 15 tapers and the duct outlet 21 ofthe duct 2 is formed centrally at the tip, optionally slightly flaringin a nozzle shape. The attachment 3 for the syringe is placed on thetube.

In the probe according to FIG. 8, the tube end 15 likewise tapers inrounded fashion, but the outlet 21 of the duct 2 is provided laterallyat the outer surface of the tube 10 in the zone of the tube end.

We claim:
 1. A tubular flexible probe for introduction into the tracheaand, respectively, into the bronchial system, which comprises a unitarytube made of synthetic resin extending along a longitudinal axis, havinga length of about 30-50 cm and an outer diameter of about 5-8 mm, saidtube having a continuous duct extending longitudinally along said axisthrough the tube from an inlet end to an outlet end; said duct having adiameter of about 1 mm up to maximally about 2 mm for passingmedicaments and/or irrigation solution therethrough at a high flow rateand said tube having a wall thickness of at least 1.5 mm, with an outerdiameter of the tube of 5 mm, and at least about 3 mm, with an outerdiameter of 8 mm, and an attachment for connection of a syringe for themedicaments and/or irrigation solution being arranged at the inlet endof the duct; an end of the tube adjacent to the outlet end of the ductbeing tapered in a rounded fashion.
 2. A probe according to claim 1,wherein the duct has a diameter of about 1 to 1.5 mm.
 3. A probeaccording to claim 1 or claim 2, wherein the attachment is formedintegrally with the inlet end of the duct.
 4. A probe according to claim1, wherein the outlet end of the duct is located on an outer surface ofthe tube.
 5. A probe according to claim 1, wherein an outer surface ofthe wall of the tube is equipped in an axial longitudinal extension withan X-ray contrast strip.
 6. A probe according to claim 1, wherein theoutlet end of the duct flares outwardly.
 7. A probe according to claim1, wherein the attachment is provided with a closure means.